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临床试验/NCT07245966
NCT07245966已完成不适用

Pharmacokinetics and Pharmacodynamics of High Dose Ceftriaxone in Patients With Sepsis

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Probability of target attainment of the pharmacodynamic index fT>MIC ≥ 100% for ceftriaxone

研究概览

简要总结

As the general treatment method for infectious diseases is to prescribe antibiotics which can be complete at the empirical treatment with the control of the sources of infection, the types of antibiotics that contain the broad spectrum and the proper dose to reduce the severity of infection play an important role. Especially, patients with sepsis should receive antibiotics within 1 hours after the diagnosis since the delay of 1 hour will decrease the rate of survival by 7.6 percent. Ceftriaxone is considered to be Cephalosporin, the antibiotics in the group of β-lactams antibiotic which kills bacteria by preventing the creation of significant cell walls. Ceftriaxone is soluble and can be excreted by the kidney. It is a β-lactams broad spectrum which can kill bacteria broadly including various types of gram-positive and gram-negative. The effectiveness of Ceftriaxone is in accord with the percentage of time that the level of the drug is beyond the minimum inhibitory concentration. According to the research in animals conducted by Craig WA and others, the drug effect to prevent the bacteria growth will occur when the %ft>MIC is more than at least 40%. The rate of prevention will reach the maximal bactericidal effect when the %ft>MIC is equal to 60 to 70%. At the moment, physicians prefer the 60 to 70% of %ft>MIC in the group of Cephalosporins drugs as the main pharmacodynamics to cope with infections.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants aging over 18 years old with the symptoms of systemic inflammatory response syndrome (SIRS) which requires at least two of the following symptoms
  • Temperature over 38 degree Celsius (Fever) or lower than 36 degree Celsius (hypothermia)
  • Tachycardia
  • Tachypnea, or the detection of PaCO2 under 32 mmHg, or hypocapnia due to hyperventilation
  • Participants are about to received Ceftriaxone by the physician
  • Weighting equal to or more than 50 kg

排除标准

  • Patients with the clinical record of the severe allergy to β-lactam or Ceftriaxone
  • Patients received Ceftriaxone within 3 days before the participation
  • Having a culture result of being resistant to Ceftriaxone
  • Having CLcr lower than 50 ml/min, or receiving hemodialysis, or renal replacement therapy
  • Meningitis patients
  • Decompensated liver disease
  • Pregnant and lactating
  • Septic shock patients
  • Having the level of serum albumin lower than 2.5 g/dl

结局指标

主要结局

Probability of target attainment of the pharmacodynamic index fT>MIC ≥ 100% for ceftriaxone

时间窗: First 24 hours of ceftriaxone treatment

The percentage of simulated patients achieving the pharmacodynamic target of free drug time above MIC (fT\>MIC ≥ 100%), estimated using population pharmacokinetic modeling incorporating observed plasma concentration-time data and pathogen-specific MIC values or reference MIC distributions.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarunyou Chusri

Assoc. Prof. Sarunyou Chusri M.D. Ph.D.

Prince of Songkla University

研究点 (1)

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